Device approvals, testing, diagnostics, safety alerts, and technology updates.
Stryker’s March 2026 cyberattack is a reminder that patients can feel the effects of a vendor disruption through shipping delays, manual workarounds, and some rescheduled procedures, even when their hospital was not directly hacked.
A new Nature Medicine study suggests a blood-based model may help estimate when Alzheimer’s symptoms could begin, but the research is not a consumer screening test. Here’s what the study actually found, what U.S. patients can access now, and why memory symptoms still need a full medical workup.
Roche’s FDA-cleared pTau181 blood test brings Alzheimer’s biomarker testing closer to everyday care, but right now it is mainly for adults 55 and older who already have cognitive symptoms, and a positive result still usually needs more workup. ([accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252163))
AI tools are increasingly used in imaging, diagnostics, and clinical decision support. Here’s how the FDA regulates artificial intelligence as medical devices, what Software as a Medical Device (SaMD) means, and what patients should know about safety, updates, and limits in 2026.
Artificial intelligence is increasingly used in imaging, heart monitoring, and disease screening. Here’s how the U.S. Food and Drug Administration regulates AI-enabled medical devices — and what that oversight means for patient safety, transparency, and trust.
The FDA continues to monitor rare cancers linked to breast implants, including BIA-ALCL and emerging reports of BIA-SCC. Here’s what patients need to know about symptoms, risk levels, informed consent, and insurance coverage.
OTC hearing aids are now widely available for adults with mild to moderate hearing loss. Here’s what the FDA requires, how they differ from prescription devices, what traditional Medicare does and does not cover, and when a medical exam is still essential.
AI tools are increasingly used in U.S. hospitals and clinics, but not all of them are regulated the same way. Here’s how the FDA oversees AI-enabled medical devices, what clearance really means, and what patients should ask when AI is involved in their care.
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